FDA WARNING_LETTER - Dongguan Dalang Vigor Electronics Mfy. - June 16, 2011

On June 13-16, 2011, an FDA inspection of Vega Technologies, Inc. in Dongguan City, Guangdong, China, revealed that the firm's nebulizers and thermometers are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain adequate procedures for validating device design (21 CFR 820.30(g))**: The firm did not adhere to its risk management procedure for the SU-01 suction pump, using a different method than required. Acceptance criteria for design validation activities for the SU-01 were not established prior to validation. The firm's response was inadequate, lacking English translations for revised procedures (R205, R203) and failing to ensure training or retrospective review of other designs. 2. **Failure to establish and maintain adequate procedures for verifying device design (21 CFR 820.30(i))**: Design verification for the SU-01 suction pump did not confirm that design output met input requirements. The firm's response was inadequate, lacking English translations for revised procedures (R203, R440-2) and failing to ensure training or retrospective verification for the SU-